Job Responsibilities Design of the process validation strategy, preparation of validation documents (study design, writing protocols, and reports)
Supporting R&D teams during the process characterization phase
Reviewing and approving process characterization documents
Responsibility for validation assessments on changes and deviations (approval of deviations and changes)
Preparation and maintenance of a detailed continued process verification plan
Assessing and approving Product Quality Reviews
Requirements Master's degree in Chemistry, Biology, Biotechnology, Chemical Engineering, or equivalent
Experience in project management, preferably in Operations, MSAT, Quality, and Compliance
Experience interacting with different collaborators within an organization and with regulatory agencies (Swissmedic, FDA, etc.) is advantageous
Ability to handle multiple tasks simultaneously and meet deadlines
Proficient in English (written and spoken); proficiency in German is appreciated
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